Quality Engineer II (Wayne, NJ)
Getinge
Wayne, NJ
With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview This position is responsible for implementation and execution of Quality Engineering II. This position provides leadership and technical support for the quality assurance, process control, and engineering functions. Leads or is a key contributor to cross functional process improvement and problem-solving teams. Job Responsibilities And Essential Duties
- Leads Statistical Process Control (SPC) initiatives on EVH manufacturing lines, including data collection, trend analysis, and process capability assessments to ensure product and process stability.
- Supports and coordinates equipment qualifications and process validations (IQ, OQ, PQ, PPQ) by developing and executing protocols, synchronizing interdepartmental activities, and analyzing validation data.
- Performs detailed data analysis to identify process variation, validate sampling plans, and establish appropriate control limits across critical manufacturing and inspection processes.
- Initiates, manages, and audits ship holds to contain potential quality risks, ensuring traceability, communication, and timely resolution in coordination with Quality, Manufacturing, and Distribution teams.
- Maintains and updates distribution lists for containment, data trending, and escalation of quality issues, ensuring accurate cross-functional communication.
- Provides technical and analytical support to the Quality Control laboratories, including review of Device History Records (DHRs), support of validation activities, and updates to product and testing specifications.
- Reviews and approves qualification, validation, and change control documentation in compliance with GMP and ISO 13485 requirements.
- Conducts or supports failure investigations and complaint trending to identify root causes and drive process improvements.
- Supports the Material Review Board (MRB) through evaluation of non-conforming materials and recommendations for disposition.
- Collaborates closely with Manufacturing, Engineering, and R&D to communicate product status, deviations, and improvement opportunities, providing guidance and training as needed
- A Bachelor’s degree in Engineering, Science or related field or equivalent is required. A Master of Science in Engineering, Science or related field is preferred. CQE (Certified Quality Engineer) or CQA (Certified Quality Auditor) is desirable.
- A minimum of 3 years’ experience in quality assurance, quality engineering or related functions or a M.S. plus 1 year experience is required. Prior experience in a FDA regulated industry or ISO certified organization.
- Must have demonstrated proficiency in statistical analysis, the ability to analyze and solve complex problems, and the ability to communicate effectively across departments.
- Working knowledge of quality systems is required. Familiarity with analytical software applications is preferred.
- Project management and leadership experience is preferred. Previous experience supervising technicians and conducting and participating in FDA/customer/corporate audits is preferred.
- Must demonstrate effective influencing and change management skills and demonstrated achievements in process improvements.
- Ability to use Microsoft Office Products such as Word and Excel or equivalent software applications is preferred.
Posted 2025-10-15
Recommended Jobs
Beauty Advisor
Sephora
Edgewater, NJ
Sephora in Edgewater, NJ is seeking a part-time Beauty Advisor to deliver personalized beauty experiences and drive sales. The role involves providing expert product recommendations, staying updated o…
View Details
Posted 2025-10-14
Swimming Pool Construction Manager
V Lehmann Construction Co Inc. DBA: Lehmann Pools & Spas
Mahwah, NJ
Job Description Job Description Lehmann Pools & Spas is a high-end Swimming Pool company that has been providing service and maintenance for commercial and residential pools we have built, as wel…
View Details
Posted 2025-10-24
General Dentist
ETS Dental
Wildwood, NJ
We’re seeking a motivated dentist to join our high-performing private practice in Wildwood, NJ. The ideal candidate should be proficient in the following: Crowns & Bridges, Composites & Fillings, Roo…
View Details
Posted 2025-09-29
Delivery Driver
Delivery Nation
Northfield, NJ
Job Description Job Description Delivery Nation: Currently hiring Float/Food Delivery Drivers to join our team. We are a staffing company that schedules delivery drivers to deliver in a loca…
View Details
Posted 2025-09-20
Night Store Sales Manager
LEGACY FUDGE LLC
Cape May Court House, NJ
Job Description Job Description Come to the beach, enjoy your work, and the view! Benefits/Perks - Competitive wages Career Growth Opportunities Fun and Energetic Environment Ongoing …
View Details
Posted 2025-10-20
Customer Support Specialist
Giftogram
Mountain Lakes, NJ
Customer Support Specialist Location: Full-Time, In-Office | Whippany, New Jersey The Role At Giftogram, appreciation isn’t just what we do—it’s who we are. As a Customer Support Specialist…
View Details
Posted 2025-09-22